MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CCWET0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported that after surgery, the patient experienced vision is blurry at a distance, struggling driving.Clinical reason aimed for plano, mr (refraction) came out at 02.50.So, they have planned explant.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information has been provided in b.2., b.3., b.5.,b.6.,b.7.,d.6b.,d.10., and e.4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has received it states that the patient experienced fluttering in right eye.Approximately 4 weeks after surgery patient¿s mr was -2.25 and he was unable to see at distance.The iol was explanted and exchanged with another lens in a secondary procedure.There was no impact to the patient and issues resolved.

• Brand Name: CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20748252
• Report Number: 1119421-2024-02278
• Device Sequence Number: 20925808
• Product Code: POE
• UDI-Device Identifier: 00380652405737
• UDI-Public: (01)00380652405737(17)270214(11)230216(10)15590088
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.180
• Device Lot Number: 15590088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/09/2024
• Date Device Manufactured: 02/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH II LOADING FORCEPS.; MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown